ottobock 24H1 MyCRO Temporary Orthosis to Aid Instruction Manual

ottobock 24H1 MyCRO Temporary Orthosis to Aid

Product description

INFORMATION
Date of last update: 2022-08-11

• Please read this document carefully before using the product and observe the safety notices.
• Obtain instruction from the qualified personnel in the safe use of the product.
• Please contact the qualified personnel if you have questions about the product or in case of problems.
• Report each serious incident in connection with the product, in particular a worsening of the state of health, to the qualified personnel.
• Please keep this document for your records.

The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

Indications for use and Contraindications

Indications for use
Intended for medical purposes for use on children from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including children with plagiocephalic, brachy­cephalic, and scaphocephalic shaped heads by applying mild pressure to prominent regions of a child’s cranium in order to improve cranial symmetry and/or shape. These devices are also indic­ated for adjunctive use for children from 3 to 18 months of age whose synostosis has been surgic­ally corrected, but who still have moderate-to-severe cranial deformities including plagio cephalic-, brachycephalic -, and scaphocephalic- shaped heads.
The orthosis must be used in accordance with the indications.

Contraindications
Not for use on children with pre-surgical craniosynostosis or hydrocephalus.

Safety

Explanation of warning symbols

• Warning regarding possible serious risks of accident or injury.
• Warning regarding possible technical damage.

General safety instructions

WARNING!

• The product may be used only by the person it was made for.

• Observe the notices regarding intended use and the use of the product.

•  Check the product for damage prior to each application.

• Evaluate the elastic band for damage and proper seating prior to each application to reduce the potential for the elastic band to slip out of place which could create a choking hazard.

• Evaluate the structural integrity and fit of the orthosis to reduce the potential for the orthosis to slip out of place which could cause asphyxiation or trauma to the child’s eyes or skin.

• Do not continue to use a damaged product, and contact your orthotics and prosthetics profes­sional (O&P professional).

• The expandable clasp is designed to accommodate the child’s growth; if the clasp reaches maximum expansion, or if there are indications that the child has outgrown the orthosis during treatment, contact your O&P professional for a follow up appointment.

• Evaluate the child’s skin at frequent intervals for signs of irritation or breakdown. Mild eryth­ema, edema and pressure sores, can be expected during the use of a cranial orthosis.

• Check the areas of skin that come into contact with the product before and after each use.

• Only use the product on intact skin.

• Note that using the product on a shaved head may cause ingrown hairs.
  Potential adverse effects

• Skin irritation or breakdown.

• Potential adverse effects caused by extending treatment against medical advice. Extended treatment can cause skin irritation, skin breakdown and may result in excessive pressure.

NOTICE!

Risk of product damage and limited functionality

• During normal use, the product should not be exposed to temperatures lower than -10 °C (14 °F) and higher than +45 °C (113 °F).
• Clean the product if it was in contact with salt water or water containing chlorine.
• Observe the instructions for cleaning and care.

Scope of delivery

Handling

WARNING
Failure to comply with the examination intervals
Risk of injury due to improper use of the product

Comply with the examination intervals established with your O&P professional in order to ensure the safe use of the product.

INFORMATION
Wearing the orthosis in a child car seat is permissible. The child car seat must be adjusted so the child can sit in it properly with the orthosis.

During the first few days, the orthosis is worn for shorter periods of time so the child can become accustomed to it (see the table below). The orthosis should subsequently be worn all day and all night (23 hours minimum) in order to obtain the best possible results. The orthosis should be worn with as few interruptions as possible, e.g. removed only for bathing or treatment by a physiotherapist. Wearing the orthosis can cause increased perspiration during the first two to three weeks. This is normal and decreases over time.
If treatment is required for other illnesses such as torticollis during therapy with the MyCRO Band, the orthosis may be removed briefly.
If wearing the orthosis is interrupted for an extended period of time, another familiarisation period may be required.
CAUTION: If there is a problem with the orthosis make an appointment with your O&P professional immediately . Do not wait until your next scheduled appointment. It is important that the orthosis is worn consistently.

Application

WARNING
Wearing the orthosis in case of fever Risk of injury due to overheating

Stop using the orthosis in case of fever.

WARNING
Incorrect or excessively tight application of the product to the body
Risk of pressure points and constriction of blood vessels and nerves due to improper applica­tion

• Ensure that the product is applied properly and fits correctly.
• Do not continue to use the product if it fits incorrectly.

1. Check the following points before putting on the orthosis:
   • The child is in a stable position with no interfering objects or items near the head.
   • Any lotions or creams used have been absorbed by the skin.
   • The orthosis is in proper condition with no cracks or other damage.
   • The lining fits inside the orthosis without wrinkles and projects slightly beyond the hard edge all around.
2. Using the finger slot, grip elastic band to detach from clasp (see fig. 1).
3. Carefully pull the orthosis apart at the closure (see fig. 2).

4. Align the orthosis and place it onto the child’s head (see fig. 3).
5. Check the fit of the orthosis:
   • The arrowhead on the front should form a vertical line with the middle of the nose.
   • The orthosis has to leave the ears and eyes uncovered.
   • The lining should project beyond the edge of the orthosis all around and protect the skin against contact with the plastic.
6. If the orthosis fits correctly: Hold the orthosis carefully so it cannot shift and fasten the closure. A gap in the closure is normal and no cause for concern.
7. Verify that the elastic band fits properly in the guide of the closure.
8. CAUTION! To avoid injuries, always open the closure before positioning the orthosis.
   If the orthosis does not fit correctly or has shifted: Repeat the previous steps.

Removal
INFORMATION
Redness of the skin after removing the orthosis is not unusual, and should go away within 2 hours. If the redness does not go away, or if pressure points develop, contact your O&P professional.

Prerequisite: The child is in a stable position with no interfering objects or items near the head.

1. Open the elastic band of the closure.
2. Carefully pull the orthosis apart at the closure.
3. Take the orthosis off the child’s head.
   TIP: Gently massage the child’s head with your fingertips after removing the orthosis in order  to promote self-perception.
4. Remove the lining from the orthosis and clean it (see page 10). Insert the replacement lining into the orthosis.

Changing the lining
The lining is attached to the orthosis with micro-hook. It has to fit inside the orthosis without wrinkles and must be in contact with the orthosis over the entire surface area.

Removing the lining

1. Detach the folded lining in the neck area.
2. Starting at the closure, detach the lining all around the orthosis.

Inserting the lining

1. Roll up the lining into a tight roll (see fig. 5).

2. WARNING! Ensure that the lining is smooth and securely fastened to the microhooks, to avoid pressure points due to bunching of the lining.
   Position the lining at the closure of the orthosis. Carefully unroll the lining, pressing it into the orthosis without wrinkles (see fig. 6).

3. Ensure that the lining projects slightly beyond the hard edge all around.

4. In the neck area, fold over the lining to the outside and press it into place (see fig. 7).

Replacing the elastic band

INFORMATION
The elastic band that holds the closure is intended to last the lifetime of the orthosis. If the elastic band needs to be replaced during treatment, use the following instructions.

Prerequisite: Orthosis is taken off

1. Remove the lining from the orthosis.

2. Inside the orthosis: Carefully, remove the elastic band with a small tool (e.g. an allen key) from the pin that holds it in place.

3. Remove the elastic band.

4. Outside the orthosis: Push a new elastic band through the opening.

5. Inside the orthosis: Push the new elastic band in place around the pin.

6. Outside the orthosis: Pull on the elastic band to test if it is secured properly.

7. Re-attach the lining (see page 7).

Cleaning

NOTICE
Improper cleaning
Damage to the product due to improper cleaning

• Only clean the product with the approved cleaning agents.
• Only clean the product by hand.

INFORMATION
Remove the lining from the orthosis before cleaning. Clean the lining and the shell of the orthosis separately.

Recommended cleaning agent: pH neutral soap

1. Clean the product by hand with clean water and a pH neutral soap.
2. Rinse the soap away with clean water.
3. Dry the product with a soft cloth.
4. Allow to air dry fully before donning.

Disposal

Return the product to the O&P professional for disposal.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorised modification of the product.

Local Legal Information
Caution: Federal law restricts this device to sale by or on the order of a qualified orthotist or physician or any other practitioners licensed by the law of the State in which that person practices to use or order the use of the device.

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